Single use Surgical Optical Fiber

GUDID 08033945934378

Single use Surgical Optical Fiber Ø 400 µm

QUANTA SYSTEM SPA

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 08033945934378
• NIH Device Record Key: 62d61f12-c665-4908-ab09-1405c6e74c3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single use Surgical Optical Fiber
• Version Model Number: OAF004001
• Company DUNS: 436045833
• Company Name: QUANTA SYSTEM SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033945934378 [Primary]
GS1	08033945935283 [Package]; Package: carton [5 Units]; In Commercial Distribution
GS1	08033945935641 [Package]; Contains: 08033945935283; Package: carton [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131473

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-07
• Device Publish Date: 2016-08-29

On-Brand Devices [Single use Surgical Optical Fiber]

• 08059173391202: Single use ball-tip 272 micron Sterile Surgical Optical Fiber
• 08059173392162: Single use Surgical Optical Fiber Ø 150 µm
• 08033945938826: Single use Ball tip Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologi
• 08033945938802: Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Americ
• 08033945938741: Single use ball-tip 272 micron Sterile Surgical Optical Fiber
• 08033945938451: Single use Surgical Optical Fiber ø 1000 µm. Distributed by Olympus Surgical Technologies Amer
• 08033945938727: Single use Surgical Optical Fiber ø 550µm. Distributed by Olympus Surgical Technologies Americ
• 08033945938710: Single use Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies Ameri
• 08033945938703: Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Americ
• 08033945938697: Single use Surgical Optical Fiber ø 200µm. Distributed by Olympus Surgical Technologies Americ
• 08033945938390: Single use ball-tip 272 micron Sterile Surgical Optical Fiber
• 08033945938307: Single use Ball tip Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologi
• 08033945938246: Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Americ
• 08033945938147: Single use Surgical Optical Fiber ø 365 µm. Distributed by Olympus Surgical Technologies Ameri
• 08033945938086: Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Americ
• 08033945937997: Single use Surgical Ball tip Optical Fiber ø 272 µm. Distributed by Olympus Surgical Technolog
• 08033945937935: Single use Surgical Optical Fiber ø 1000 µm. Distributed by Olympus Surgical Technologies Amer
• 08033945937812: Single use Surgical Optical Fiber ø 550µm. Distributed by Olympus Surgical Technologies Americ
• 08033945937690: Single use Surgical Optical Fiber ø 200µm. Distributed by Olympus Surgical Technologies Americ
• 08033945937485: Single Use Surgical Optical Fiber ø 800 µm Distributed by Cogentix.
• 08033945937478: Single Use Surgical Optical Fiber ø 550 µm Distributed by Cogentix.
• 08033945937461: Single Use Surgical Optical Fiber ø 365 µm Distributed by Cogentix.
• 08033945937454: Single Use Surgical Optical Fiber ø 272 µm Distributed by Cogentix.
• 08033945937072: Single use Surgical Optical Fiber ø 365 µm
• 08033945937041: Single use Surgical Optical Fiber ø 272µm
• 08033945936754: Single use Performance Surgical Optical Fiber Ø 365 µm
• 08033945936747: Single use Precision Surgical Optical Fiber ø 272µm
• 08033945936730: Single use Performance Surgical Optical Fiber Ø 365 µm
• 08033945936723: Single use Precision Surgical Optical Fiber ø 272µm
• 08033945936716: Single use Performance Surgical Optical Fiber ø 365 µm
• 08033945936709: Single use Precision Surgical Optical Fiber ø 272µm
• 8033945936242: Single use Surgical Optical Fiber Ø 1000 µm Manufactured for Edap Technomed Inc.
• 8033945936235: Single use Surgical Optical Fiber Ø 800 µm Manufactured for Edap Technomed Inc.
• 8033945936228: Single use Surgical Optical Fiber Ø 550 µm Manufactured for Edap Technomed Inc.
• 8033945936211: Single use Surgical Optical Fiber Ø 365 µm Manufactured for Edap Technomed Inc.
• 08033945936020: Single use Surgical Optical Fiber ø 272 µm Manufactured for Edap Technomed Inc.
• 8033945936198: Single use Surgical Optical Fiber ø 200µm Manufactured for Edap Technomed Inc.
• 08033945934873: Single use Surgical Optical Fiber ø 400 µm
• 08033945934484: Single use Surgical Optical Fiber Ø 272 µm
• 08033945934453: Single use Surgical Optical Fiber Ø 200 µm
• 08033945934422: Single use Surgical Optical Fiber Ø 1000 µm
• 08033945934408: Single use Surgical Optical Fiber Ø 800 µm
• 08033945934378: Single use Surgical Optical Fiber Ø 400 µm
• 08033945933654: Single use Surgical Optical Fiber Ø 1000 µm
• 08033945933647: Single use Surgical Optical Fiber Ø 800 µm
• 08033945933630: Single use Surgical Optical Fiber Ø 600 µm
• 08033945933623: Single use Surgical Optical Fiber Ø 550 µm
• 08033945933616: Single use Surgical Optical Fiber ø 365 µm
• 08033945933609: Single use Surgical Optical Fiber ø 272µm
• 08033945933548: Single use Surgical Optical Fiber Ø 1000 µm